EU MDR Derogations: Article 59 and Article 97 Scope and Limits

1. Key takeaways

The MDR provides two derogation channels. Under Article 59, a Member State competent authority may authorise, on a case-by-case basis, the placing on the market of devices without the conformity assessment procedures. Under Article 97, an EU-level procedure exists under which the Commission may require Member States to take necessary measures, or take such measures itself, in specific situations. Both channels are exceptional routes and do not constitute a regular option for selling without CE.

The distinction between the two channels matters because they answer different scenarios and operate at different levels. Article 59 is national, discretionary, reasoned and time-limited; it exists for situations in which denying patients access to a device would be contrary to public health or patient safety. Article 97 is a Union safeguard mechanism directed at non-compliant situations on the market, and its use in transitional contexts has been explicitly narrowed by Commission guidance. Neither channel can be planned into a commercial strategy: applications are granted only in documented individual cases, and relying on derogations as a substitute for certification exposes the business to enforcement, withdrawal of devices and reputational damage. Their proper place in a compliance plan is as emergency scenarios with defined triggers, not as supply continuity tools.

2. Legal basis

Both derogation channels and the reverse-direction procedure of Article 95 are contained in Regulation (EU) 2017/745, adopted on 2017-04-05 and applicable since 2021-05-26. The transitional applicability of Article 97 was clarified in MDCG 2022-18 Add.1, dated 2023-06, issued by the European Commission in the context of the transitional arrangements introduced by Regulation (EU) 2023/607. Together these three texts define both the theoretical availability of the derogations and their practical limits during the transition period.

3. Expert insights

Insight one: an Article 59 derogation is an authorisation that is case-specific, time-limited and reasoned, not an exemption regime.

An authorisation under Article 59 is granted by a Member State competent authority, must be based on reasons of public health, patient safety or health protection, and usually carries a defined period and defined beneficiaries. Treating it as a scheme for placing products on the market first and obtaining certificates later has no legal basis. The authorisation is tied to the individual case that justified it, and its expiry returns the device to the normal regime, meaning that certification work must continue in parallel throughout the derogation period. Companies that present derogations to investors or customers as a stable market access route create expectations that the legal framework does not support.

Insight two: Article 97 has been explicitly narrowed in the transitional context.

MDCG 2022-18 Add.1, dated 2023-06, explains the transitional arrangements following the entry into force of (EU) 2023/607: the use of Article 97(1), which competent authorities had previously employed to keep devices on the market while awaiting MDR certificates, has achieved its purpose and is no longer relevant. This narrowing directly closed a buffer channel that had once been available. Manufacturers and authorised representatives should update their internal guidance accordingly, because plans built around the earlier practice of holding devices on the market under Article 97 pending certification are no longer a valid fallback under the clarified framework.

Insight three: eligibility for the transitional extensions and the Article 59 and Article 97 derogations are two separate mechanisms.

Eligibility for the extensions under Article 120(3a) to (3c) depends on whether five conditions are met, including the quality management system, the formal application and the written agreement. A derogation is a separate, individual authorisation. The two cannot substitute for each other: a company that fails to meet the extension conditions cannot fall back on derogations to maintain supply. This separation is deliberate and prevents the transitional regime from being circumvented through the safeguard provisions. Planning should therefore treat the five conditions as the only reliable route to continued supply of legacy devices, and treat the derogation channels as exceptional tools with independent legal tests.

Insight four: Article 95 is the reverse procedure, aimed at devices already on the market.

Article 95 sets out the procedure competent authorities must follow for devices presenting an unacceptable risk. It runs in the opposite direction to the derogations: one lets devices in, the other takes devices out. When a manufacturer receives a notification from a competent authority under Article 95, it must cooperate through the procedure and provide the requested information within the specified timelines. Because Article 95 proceedings can lead to withdrawal from the market, the response should be prepared with the same rigour as the original certification file, including risk evidence, corrective action proposals and communication plans for affected customers and health institutions.

4. Practical recommendations

1. Do not include Article 59 derogations in business plans or delivery commitments; keep them as contingency options for extreme situations with documented triggers.
2. When assessing transitional eligibility, self-check strictly against the five conditions of Article 120(3c) and do not plan on derogations as an alternative.
3. Maintain regular communication with the competent authority of the Member State of the authorised representative, and understand the actual acceptance practice of that country for Article 59 requests.
4. Establish a response process for notifications from competent authorities under Article 95, defining the internal lead and the response timelines for each required step.
5. Integrate the conclusion of MDCG 2022-18 Add.1 on the narrowing of Article 97 into the internal risk assessment, and remove obsolete fallback plans from operating documents.

5. Verification checklist

• □ It has been confirmed that no Article 59 derogation is relied upon as a routine market access plan
• □ The transitional eligibility self-check against the five conditions of Article 120(3c) has been completed
• □ The acceptance practice of the target Member State for Article 59 has been understood
• □ A response process for notifications under Article 95 has been established
• □ The conclusions of MDCG 2022-18 Add.1 have been incorporated into the risk assessment
• □ The period and scope of any derogation authorisation, if held, have been recorded

GRZAN supports manufacturers, authorised representatives and importers across the EU MDR market with CE marking pathway selection and classification strategy, including transitional eligibility assessments under Article 120(3c), competent authority communication and contingency planning for derogation scenarios. For a practical estimate of compliance timelines and documentation effort for your portfolio, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 2026-10-29.